Childhood Obesity Treatment Designed for Low Income and Hispanic Families

Summary

This study is a type-1 hybrid effectiveness-implementation RCT comparing a novel family-inclusive childhood obesity treatment program, the "Healthy Living Program" (HeLP), to a protocol that enhances usual primary care to deliver Recommended Treatment of Obesity in Primary Care (RTOP). Children with obesity and their families will be referred to the study by primary care providers and randomized to HeLP or RTOP. The clinical setting is a practice-based research network serving majority Hispanic and Medicaid-insured populations. The intensive phase and booster sessions of HeLP will take place at recreation centers located near the clinics and will be led by health educators employed by the clinics. Visits with primary care providers (PCPs) for HeLP maintenance or RTOP will occur at the clinics.

Conditions

• Pediatric Obesity
• Healthy Eating
• Physical Activity
• Minority Health
• Mindfulness
• Family
• Counseling

Interventions

BEHAVIORAL

The Healthy Living Program/La Vida Saludable

A whole-family group childhood obesity intervention delivered at community recreation centers

BEHAVIORAL

Recommended Treatment of Obesity in Primary Care

A healthy lifestyle counseling protocol that enhances usual primary care

Sponsors & Collaborators

• Colorado State University

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Matthew A Haemer, MD MPH · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-15

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• United States

Study Locations